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FDA Tobacco Bill Gains Momentum in Congress

Apr 4, 2008 | Parker Waichman Alonso LLP

Tobacco products might soon face regulation by the Food & Drug Administration (FDA).  A bill granting the FDA jurisdiction to regulate cigarettes and other forms of tobacco was approved by the House of Representatives Energy and Commerce Committee Wednesday, setting up its passage by the full House.

Tobacco products are among the least regulated consumer products on the market.  Yet, tobacco use is the number one preventable cause of death in America. Every year, smoking and other tobacco use kill more than 400,000 Americans and cost the nation more than $96 billion in health care bills.

On Wednesday, the House panel approved the FDA tobacco bill by a margin of 38-12.  The measure has gained substantial bipartisan support, with 11 Republicans supporting it, including one — Mike Rogers of Michigan — who had voted against the bill when the Health Subcommittee marked it up March 13.  The 12 “no” votes all came from Republicans, some of whom cited the measure’s potential effect on the FDA itself.

The FDA tobacco bill has more than 200 co-sponsors in the House, and it now also has support from some tobacco industry interests, such as the biggest U.S. smokeless tobacco maker, that had until recently opposed it.  That's because the drafters of the FDA tobacco bill made key concessions the industry supports, such as prohibiting the FDA from instituting a ban on tobacco products, or requiring tobacco manufacturers to zero out nicotine.

The FDA tobacco bill, drafted by Rep. Henry Waxman (D-Calif), would among other things, allow the FDA to set product standards, which could include limiting certain ingredients in cigarettes. Tobacco makers would have to turn over to the agency extensive information and win FDA approval for claims that products carry reduced health risks. The agency would get the ability to regulate advertising of tobacco products.

According to CQ.com, a Senate version of the bill was approved by the Health, Education, Labor and Pensions Committee on Aug. 1. The full Senate is expected to debate the bill in the next few months. A report in The Walls Street Journal said all three presidential candidates -- Democratic Sens. Barack Obama and Hillary Clinton and Republican Sen. John McCain -- are co-sponsors of the Senate version of the FDA tobacco bill.

While backers of the FDA tobacco bill hope the House will vote on it sometime this spring, there are still substantial obstacles to its passage.  The FDA commissioner has already raise concerns about the bill, and there is a good chance that the President will veto it when it comes to his desk.  Opponents have also argued that the FDA, which has been faulted by many for its handling of drug and food safety, isn't up to handling tobacco regulation.